VP Clinical Affairs – Cardiovascular and Neurovascular US
United States | 🫀 Class III Medical Devices | Executive Leadership
I'm partnering with a growing cardiovascular and neurovascular medical device company in the US that is looking to appoint a VP, Clinical Affairs to lead its clinical strategy through an active IDE pivotal trial and toward PMA approval .
This is a high-impact leadership opportunity for a clinically driven executive who can build scalable trial strategies, develop high-performing teams and shape the path to commercial approval.
Key responsibilities:
- Own clinical strategy and trial design for an active IDE pivotal program
- Partner directly with regulatory affairs on the path to PMA
- Build, lead and scale the clinical affairs function as headcount grows
- Lead relationships with CROs, principal investigators and KOLs across trial sites
- Sit on the leadership team, partnering with CEO, CMO and R&D on product and trial-design decisions
- Own clinical data strategy and reporting in partnership with biostatistics
- Support clinical sections of FDA submissions
- Represent the company externally with investors, KOLs and at scientific/clinical conferences
Ideal background:
- Senior clinical affairs leadership experience within cardiovascular or neurovascular medical devices
- Proven track record running IDE trials through to PMA
- Strong understanding of the US Class III clinical pathway
- Experience building and managing a clinical affairs team, not just running trials individually
- Strong investigator/KOL relationships and clinical network
- Entrepreneurial, hands-on leadership style with the ability to operate in a growth environment
This is an opportunity to join an organization with significant growth ambitions and have a direct impact on its clinical strategy and path to approval .
Interested? Send me a message directly or connect with me for a confidential conversation.
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